The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in September-October, 2018.
Composition for Inducing Proliferation or Accumulation of Regulatory T Cells; K. Honda, K. Atarashi, K. Itoh, and T. Tanoue, Th e University of Tokyo, Japan; U.S. Patent # 10,092,603; October 9, 2018.
Inventors of the present invention have disclosed a treatment of infectious diseases, autoimmune diseases and allergic diseases by delivering purified bacterial mixture of at least four live bacterial strains belonging to Clostridium clusters to the intestine. This bacterial mixture is isolated from humans and upon its delivery to the intestine, it induces proliferation or accumulation of regulatory T cells. Regulatory T cells maintain homeostasis of human immune system. Induction of regulatory T cells produces IL-10, an anti-inflammatory cytokine, and in turn can be used in the treatment of infectious diseases, autoimmune diseases and allergic diseases.
Intranasal Administration; R.P. Hafner; OptiNose AS, Norway; U.S. Patent # 10,112,021, October 30, 2018.
The present invention describes the intranasal administration of proteins, such as insulin and their analogues. The intranasal administration of proteins would be in the upper posterior region of a nasal cavity of a subject, and the olfactory bulb region. The patent claims the method of delivering the formulation through a nozzle of a nose-piece of a delivery device into the nasal cavity of the subject. This provides uptake of the protein to the CNS without triggering an immune response.
Multiphasic Contraceptive Regimen for Oral Combination Drug Formulation of Progestin and Estrogen; A. Rubin; Arstat, Inc., USA; U.S. Patent # 10,111,887; October 20, 2018.
The patent describes the multiphasic contraceptive dosing regimen in females including administration of an oral combination drug formulation. The formulation comprises progestin and estrogen as multiphasic combined oral contraceptives that resolve the deficiencies of existing multiphasic combined oral contraceptives. The present invention provides safe and reduced undesirable side effects of currently used multiphasic combined oral contraceptives. There is a 21 day dosing of active product followed by seven day dosing of placebo. The active product phase is biphasic with fixed dosing for fourteen days followed by an incremental dose for the next seven days.
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Nested Particles and the Use Thereof for Coordinated Delivery of Active Agents; E. Blanco; The Board of Regents of the University of Texas System, USA; U.S. Patent # 10,076,509, September 18, 2018.
The present invention discusses nested nanoparticles for a coordinated delivery of active agents for prevention and treatment of diseases such as cancer. These particles comprise a core element and cyclodextrin coating surrounding the core element. The term nested is used here because of their layered particle compositions for example polymer nanoparticles encased in cyclodextrin shell. Different therapeutic agents and imaging agents can be bound, one to the core element and second to the coating to achieve coordinated drug release.
Dry Powder Inhaler (DPI) Designs for Producing Aerosols with High Fine Particle Fractions; P.W. Longest, M. Hindle, Y.J. Son, S.R.B. Behara, and D. Farkas; Virginia Commonwealth University, USA; U.S. Patent # 10,105,500; October 23, 2018.
Dry powder inhalers (DPIs) are most effi cient at delivering medicines to the lungs when they form aerosols with large numbers of small particles. The above invention provides methods and devices for improved dispersion and deagglomeration of dry powders and new formulations. It also provides sub-micrometer combination particle DPI formulations that incorporates one or more drugs, hygroscopic excipients, dispersion agents and surface-active agents into a combination particle. The ratio of each component can be optimized to ensure maximized drug load and optimal dispersibility. The design provides a three-dimensional array of rods (3D rod array) to increase aerosol dispersion. Previous devices increased dispersion using designs such as constriction tubes, impaction surfaces, two-dimensional meshes, and high-speed jets. However, a three-dimensional (3D) array of rods is capable of improved drug aerosol dispersion and creating higher fi ne particle fractions (FPF’s) compared with previous designs at either the same flow rate or same pressure drop.
Pharmaceutical Compositions for High-Capacity Targeted Delivery; W. H. Gmeiner; Wake Forest University Health Sciences, USA; U.S. Patent # 10,105,446; October 23, 2018.
This patent describes aptamers and compositions of the same. The word Aptamer is derived from the Latin terms “aptus” meaning to fi t and “meros”, meaning part. Aptamers are single stranded DNA or RNA molecules. They are extremely versatile and bind targets with high selectivity and specificity. In some embodiments, the aptamer selectively binds a protein of interest such as an extracellular receptor protein of interest. In some embodiments, the aptamer is directly linked by covalent bonding (e.g., via a geminal diamine linkage) to from 2 to 10 toxin compounds. The examples of toxin componds can be – doxorubicin, daunorubicin, paclitaxel and docetaxel. The patent also describes a method of selecting an aptamer that specifically binds to a protein expressed by a cell of interest.
Methods for the Treatment of Vascularizing Cancers; A. S. Chi; MacroGenics, Inc., USA; U.S. Patent # 10,100,115; October 16, 2018.
Glioblastomas are the most common primary tumor of the central nervous system (CNS), and are the deadliest of human cancers. The patent provides therapeutic compositions for the treatment of vascularizing cancers, particularly Glioblastoma. It also provides method of treating a vascularizing cancer comprising administering to a patient, a molecule having a binding ability that is specific for B7-H3 and a molecule having a binding ability that is specific for a cell-surface factor, or a receptor that promotes tumor angiogenesis, the molecule being a bi-specific antibody or a bi-specific diabody.